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Vaccine injury lawyer delivers scathing rebuke of childhood vaccine schedule — Offit, Hotez decline to debate

By Michael Nevradakis, Ph.D. | The Defender | December 5, 2025

The Centers for Disease Control and Prevention’s (CDC) vaccine advisory committee today heard from a vaccine injury lawyer who proposed the committee revisit the childhood vaccine schedule.

Attorney Aaron Siri told members of the Advisory Committee on Immunization Practices (ACIP) that the vaccines were recommended without sufficient data and that the expansion of the schedule coincided with a rise in chronic illness among U.S. children.

Siri, a vaccine critic and author of “Vaccines, Amen: The Religion of Vaccines,” called for a reexamination of the childhood immunization schedule based on “robust” safety data.

Siri challenged claims that the childhood vaccination schedule has been tested in its entirety, that the vaccines are safe and that routine childhood vaccines have been proven to prevent transmission.

He also questioned claims that scientists have conducted the testing necessary to assert definitively that there is no possible link between vaccines and autism.

Siri recommended ACIP revisit childhood vaccine recommendations based on “robust” clinical trial and post-licensure safety data and called on the committee to respect the “right of informed consent.”

“Mandates make vaccines political” and also “impact those who most need to avoid” certain vaccines, he said. When people report vaccine injuries, members of the medical community “pretend that they don’t exist.”

Siri represents plaintiffs in vaccine-related lawsuits against federal agencies and pharmaceutical companies.

Children’s Health Defense CEO Mary Holland said Siri “accurately compared the pre-1986 Act vaccine schedule with the post-1986 schedule, when doctors and vaccine manufacturers have been absolved from all real responsibility for the vast vaccine injuries they have caused,” Holland said.

The National Childhood Vaccine Injury Act of 1986 granted vaccine makers immunity from liability for most injuries caused by their products.

ACIP didn’t vote on any aspect of the childhood vaccine schedule today. In June, ACIP formed a committee to study the cumulative effect of all vaccines given during childhood.

Key vaccine advocates declined ACIP’s invitation to deliver presentations

Siri’s presentation came shortly after ACIP voted to end the recommendation that all infants born in the U.S. receive the hepatitis B (Hep B) vaccine within 12-24 hours of birth.

The committee also voted to recommend that families determine whether to give their child the Hep B shot at birth through individual decision-making and consultation with their physician.

Siri cited the licensing of Hep B vaccines as an example of flawed studies leading to the licensing of a vaccine. He called those studies “underpowered” and “industry-funded.”

Siri’s presentation stirred controversy even before it began. In a post on X yesterday, Sen. Bill Cassidy (R-La.), chairman of the U.S. Senate Health, Education, Labor & Pensions (HELP) Committee, dismissed Siri’s qualifications and said ACIP “is totally discredited.”

Siri responded that Cassidy’s post was “deeply ironic,” given that vaccine manufacturers are legally protected from lawsuits.

“Childhood vaccines are the only product in America where you cannot ever sue the company that killed or injured your child on the basis the company could’ve made the product safer. If vaccines are so safe, why do they need this protection?” Siri wrote on X.

ACIP member Dr. Cody Meissner called Siri’s presentation a “terrible distortion of all the facts” and said Siri shouldn’t have been invited. Earlier, Meissner voted against the proposal to end the universal Hep B vaccine recommendation for newborns.

ACIP also addressed controversy over Siri’s presentation and the lack of a pro-vaccine counterweight. Mina Zadeh, Ph.D., ACIP’s executive secretary, said the committee “invited several people to give us a broad perspective” on the childhood vaccination schedule.

Those invitees included two prominent and outspoken promoters of vaccines — Dr. Paul Offit and Peter Hotez, M.D., Ph.D. Both declined. Hotez told STAT that Siri “shouldn’t be there in the first place.”

Siri responded that the U.S. has “the worst health outcomes of all developed countries.”

Liability shield disincentivizes vaccine makers from performing proper safety testing

Siri used the opportunity today to criticize the National Childhood Vaccine Injury Act of 1986. He said the liability shield provided by that law disincentivized vaccine manufacturers from focusing on the safety of their products.

“Companies, including pharmaceutical companies, are driven by economic self-interest,” Siri said. “With drugs and non-routine vaccines, they … remain liable for the injuries caused by those products after they come to market and hence, they have an economic self-interest in doing robust clinical trials beforehand.”

“When it comes to routine childhood vaccines … they don’t have those same concerns,” Siri said.

He said the number of vaccines on the childhood schedule skyrocketed — from three to 72 — after Congress passed the 1986 act. Those initial three vaccines “were causing so much harm, all the manufacturers stopped making them or went out of business,” prompting the passage of the act.

“For every other product I’m aware of, the solution is to make a better, safer product. But when it came to these vaccines, Congress went a different way” by giving these companies “unprecedented broad immunity,” Siri said.

‘You can’t find what you’re not studying’

Siri also criticized the shortened clinical trial process for childhood vaccines, which results in recommendations being made on the basis of insufficient data and the inability to detect any long-term health impacts from the vaccines.

“Most recommendations for routine use by ACIP of a particular vaccine happened very shortly after its licensure, and hence the primary data often available for a specific vaccine would have been its clinical trial data,” Siri said.

He also criticized the lack of post-licensure safety monitoring.

“You can’t find what you’re not studying,” Siri said. “When you give a product to a baby or an infant in particular, you often won’t know what neurological, immunological or developmental issues that product can cause until you’ve tracked that child for at least a few years.”

Citing autism as the “injury claimed to be the most thoroughly studied,” Siri said the medical community has not conducted studies that would definitively eliminate a vaccine-autism link, even though the 1986 act listed autism as one of 11 conditions that warrant further study to determine a possible link with vaccination.

“It was a commonly claimed enough injury back in 1986 … to make it on this list of 11 conditions,” Siri said.

U.S. ‘an international outlier’ on childhood vaccination

Today’s meeting also included a presentation by Tracy Beth Høeg, M.D., Ph.D., who earlier this week was named the next leader of the FDA’s Center for Drug Evaluation and Research.

Høeg compared U.S. childhood vaccine requirements and health outcomes with those of her native Denmark. There are “eye-opening differences in the recommendations” between the two countries, she said.

While the U.S. requires 72 core childhood vaccine doses, Denmark requires 11 — in line with most other high-income countries. Høeg said this makes the U.S. “an international outlier” on childhood vaccination.

The higher vaccine load “results in an increased exposure to aluminum,” Høeg said, with U.S. children exposed to 5.9 milligrams (mg) of aluminum by age 2 and 8.0 mg by age 18. In Denmark, the corresponding figures are 1.4 and 2.9 mg, similar to other high-income countries.

While there isn’t “robust enough” data indicating “specific health concerns” resulting from this level of aluminum exposure, Høeg said there also is insufficient data to establish a safe level of exposure.

“We need to admit that we may not know what the side effects of doing this, especially all at once, could be,” she said.

Increased vaccination also hasn’t delivered better health outcomes for U.S. children, according to Høeg. She cited the examples of the Hep B and meningococcal vaccines, which Denmark does not recommend for children, unlike the U.S. Yet, levels of hepatitis B and meningitis among children in the two countries are similar.

Høeg said U.S. health agencies should “avoid overmedicalizing childhood” and owe American children recommendations that are “based on data and not politics.”

Potential risks of post-vaccine aluminum accumulation ‘a warranted concern’

Dr. Evelyn Griffin, an OB/GYN and member of three ACIP work groups called for more research into the safety of aluminum-based adjuvants used in vaccines.

Griffin said aluminum salts are the most widely used adjuvant. Yet, the mechanisms underlying the use of aluminum salts in vaccines “are not fully understood.” She said only one peer-reviewed study has examined the effects of aluminum in infants’ blood following vaccination — but that study used a small sample and didn’t collect long-term data.

According to Griffin, current FDA aluminum exposure limits are increasingly questioned, as “appropriate testing was not performed.” She said recent studies have suggested that aluminum accumulation is “a warranted concern” and called for studies on the long-term impact of aluminum exposure and who is most at risk.

Griffin called on ACIP to determine how it can assess the safety and effectiveness of adjuvants in currently recommended vaccines for all ages, including studies regarding whether multiple aluminum-containing vaccines should be administered on the same day during early infancy.

In October, ACIP announced the creation of a new work group that will study the safety of aluminum adjuvants. ACIP did not hold a vote relating to the aluminum content of vaccines at today’s meeting.

Watch the ACIP meeting here.

This article was originally published by The Defender — Children’s Health Defense’s News & Views Website under Creative Commons license CC BY-NC-ND 4.0. Please consider subscribing to The Defender or donating to Children’s Health Defense.

December 6, 2025 - Posted by aletho | Science and Pseudo-Science | ACIP, FDA, United States